Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Canakinumab

In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.

Placebo

Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.

Participant Flow for 2 periods

Period 1: Part I: Open Label

Canakinumab

Placebo

STARTED

177

0
[1]

Entered Part Ia

145

0

Entered Part Ib

142

0

Entered Part Ic

92
[2]

0

Entered Part 1d

103

0

COMPLETED

100

0

NOT COMPLETED

77

0

Death

1

0

Adverse Event

4

0

Unsatisfactory therapeutic effect

72

0

[1]

No participants received placebo in Part I.

[2]

Patients steroid free at study entry entered Part Id directly and did not participate in Part Ic.

Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid [ Time Frame: 32 Weeks ]

Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response [ Time Frame: Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) ]